Ultrasound-guided Abdominal Wall Nerve Blockade in Laparoscopic Surgery for Acute Appendicitis. (BD-TAP APP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01825863
Recruitment Status : Completed
First Posted : April 8, 2013
Last Update Posted : July 22, 2015
Information provided by (Responsible Party):
Jens Borglum Neimann, Bispebjerg Hospital

Brief Summary:

Acute appendicitis is a common disease and usually occurs within the ages of 10-30 years old." Ten percent of the population will get this disease during a lifetime." At Bispebjerg hospital it is one of the most common acute surgeries performed. Though at Bispebjerg hospital the surgery is only performed on adults as there is no pediatric ward. The surgical technique is primarily laparoscopic surgery, where the patients have their appendix removed while in general anaesthesia. During the last three years Bispebjerg hospital has had an average of 287 patients per year undergoing laparoscopic surgery. From January to the September 2012 a total of 211 patients have had the operation, with 29% having the operation performed during daytime, 48% in the evening and 22% at night. Open appendectomy is only performed in cases where laparoscopic surgery is impossible, this is often due to adhesions, scar tissue from former abdominal surgery or peritonitis. The scars from laparoscopic surgery are usually smaller than that from an open appendectomy, but it gives the patient three smaller scars divided on three abdominal quadrants instead of one larger scar on one quadrant.

The investigators want to conduct a clinical trial with fifty six patients undergoing laparoscopic surgery due to acute appendicitis. The investigators want to find out if it is possible to improve the post-operative pain management within this very large group of patients undergoing acute surgery. In detail, the investigators wish to explore whether the use of the BD-TAP blockade in the abdominal wall on patients undergoing laparoscopic surgery due to acute appendicitis, can anesthetize the patients completely or partially, so they can avoid morphine intake completely or partially during the post-operative phase (12-24 hours). The research project will be a randomized, double-blinded, controlled clinical trial.

Condition or disease Intervention/treatment Phase
Appendicitis Drug: Ropivacaine Drug: Saline 9% Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimal Postoperative Pain Management by Ultrasound-guided Abdominal Wall Nerve Blockade in Laparoscopic Surgery for Acute Appendicitis - a Randomised Controlled Trial.
Study Start Date : June 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis

Arm Intervention/treatment
Active Comparator: Active abdominal wall block
60ml ropivacaine 0.375% single shot
Drug: Ropivacaine
Placebo Comparator: Placebo abdominal wall block
60ml saline 9% single shot
Drug: Saline 9%

Primary Outcome Measures :
  1. Area under the curve (AUC), 0-12 hours, numerical rating score-pain-(NRS)0-10 [ Time Frame: 0-12 hours postoperatively ]
    Pain score (NRS) assessed when sitting up 0-12 hours postoperatively. AUC is calculated over a time frame of 0-12 hours.

Secondary Outcome Measures :
  1. Area under the curve (AUC), 0-12 hours postoperatively, numerical rating score - pain-(NRS) 0-10 [ Time Frame: 0-12 hours postoperatively ]
    NRS 0-10 is assessed 0-12 hours postoperatively. AUC is calculated 0-12 hours postoperatively.

  2. Morphine consumption postoperatively [ Time Frame: 0-12 hours postoperatively ]
    Morphine consumption postoperatively registered from the patient controlled analgesia (PCA) pump.

  3. Length of stay (LOS) in the postanesthesia care unit (PACU) [ Time Frame: Time from arrival in PACU to time of departure (measured in minutes) ]
  4. Side effects related to morphine consumption [ Time Frame: 0-12 hours postoperatively ]
    Side effects recorded: nausea and vomiting

  5. Time to first mobilisation 0-12 hours postoperatively [ Time Frame: 0-12 hours postoperatively ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age above 18 years
  • Patients undergoing diagnostic laparoscopy for acute appendicitis
  • American Society of Anaesthesiology group 1-3
  • General Anaesthesia

Exclusion Criteria:

  • Inability to cooperate
  • Inability to understand and talk danish
  • Allergic to ropivacaine
  • Drug and alcohol abuse
  • Pregnancy or nursing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01825863

Department of anaesthesiology, Bispebjerg Hospital
Copenhagen, Denmark, 2400 NV
Sponsors and Collaborators
Bispebjerg Hospital
Principal Investigator: Katrine Tanggaard, research year fellow Bispebjerg Hospital

Responsible Party: Jens Borglum Neimann, Associate professor, consultant anesthetist, PhD, Bispebjerg Hospital Identifier: NCT01825863     History of Changes
Other Study ID Numbers: BBH-BDTAP-APP
First Posted: April 8, 2013    Key Record Dates
Last Update Posted: July 22, 2015
Last Verified: July 2015

Keywords provided by Jens Borglum Neimann, Bispebjerg Hospital:
Nerve block

Additional relevant MeSH terms:
Intraabdominal Infections
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents